🏛️ Verified NIH Record • Updated 2025-12-24

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) (NCT02411448)

A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Eli Lilly and Company

🩺 Plain-English Summary (8th-Grade Level)

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B. The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (13 items).

Location: UCLA Hematology/Oncology - Santa Monica — Los Angeles, California

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
  • Serious illness or medical condition.
  • Ongoing treatment with CYP3A4 inducers or strong inhibitors.
  • Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
  • History of gross hemoptysis.
  • Significant bleeding disorders.
  • Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
  • Radiographic evidence of intratumor cavitation.
  • History of gastrointestinal perforation within last 6 months.
  • History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
  • History of any arterial thrombotic event within 6 months prior to enrollment.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (106 Sites)

Showing the first 25 of 106 sites.

  • UCLA Hematology/Oncology - Santa Monica — Los Angeles, California
  • St. Charles Health System — Denver, Colorado
  • The Gastroenterology Group, P.C. — Honolulu, Hawaii
  • Cancer Center of Kansas — Wichita, Kansas
  • Queens Medical Associates — Fresh Meadows, New York
  • Levine Cancer Institute — Charlotte, North Carolina
  • AHN Allegheny General Hospital — Pittsburgh, Pennsylvania
  • Cross Cancer Institute — Edmonton, Alberta
  • Hôpital Arnaud de Villeneuve - CHU Montpellier — Montpellier, Hérault
  • Chu Grenoble Alpes — La Tronche, Isère
  • Hopital Claude Huriez - CHU de Lille — Lille, Nord
  • Centre Hospitalier Universitaire de Poitiers — Poitiers, Vienne
  • Hôpital Européen Georges Pompidou — Paris,
  • Robert-Bosch-Krankenhaus — Gerlingen, Baden-Wurttemberg
  • Thoraxklinik Heidelberg gGmbH — Heidelberg, Baden-Wurttemberg
  • Klinikum Köln-Merheim — Cologne, North Rhine-Westphalia
  • Klinikum Chemnitz GmbH — Chemnitz, Saxony
  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH — Halle, Saxony-Anhalt
  • LungenClinic Grosshansdorf — Großhansdorf, Schleswig-Holstein
  • Helios Klinikum Emil von Behring Berlin-Zehlendorf — Berlin,
  • Sotiria Thoracic Diseases Hospital of Athens — Athens, Attikí
  • Queen Mary Hospital — Hong Kong,
  • Queen Elizabeth Hospital — Yau Ma Tei,
  • Instituto Tumori Giovanni Paolo II — Bari, Apulia
  • Cro-Irccs — Aviano, Friuli Venezia Giulia

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗